US8771268B2 - Method and system for invasive skin treatment - Google Patents

Method and system for invasive skin treatment Download PDF

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US8771268B2
US8771268B2 US13/925,832 US201313925832A US8771268B2 US 8771268 B2 US8771268 B2 US 8771268B2 US 201313925832 A US201313925832 A US 201313925832A US 8771268 B2 US8771268 B2 US 8771268B2
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skin
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Michael Kreindel
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Syneron Medical Ltd
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Syneron Medical Ltd
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Priority to US10/931,271 priority Critical patent/US20060047281A1/en
Priority to US12/702,647 priority patent/US8900231B2/en
Priority to US12/702,723 priority patent/US20100185194A1/en
Priority to US12/876,765 priority patent/US8579896B2/en
Priority to US13/925,832 priority patent/US8771268B2/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B18/0218Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques with open-end cryogenic probe, e.g. for spraying fluid directly on tissue or via a tissue-contacting porous tip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1477Needle-like probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452Skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0293Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument interstitially inserted into the body, e.g. needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1425Needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1425Needle
    • A61B2018/143Needle multiple needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1467Probes or electrodes therefor using more than two electrodes on a single probe

Abstract

A system and method for simultaneously heating a plurality of discrete skin volumes to a coagulation temperature. The system comprises an applicator containing an electrode having a plurality of spaced apart protruding conducting elements configured to contact the skin surface at a plurality of discrete locations. A controller applies a voltage to the electrode so as to simultaneously heat a plurality of skin volumes to a coagulation temperature when the applicator is applied to the skin surface.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is being filed under 35 USC 111 and is a continuation of, and claims the benefit of the filing date of U.S. Pat. No. 8,579,896, which patent had application Ser. No. 12/876,765 and which is a continuation of presently U.S. patent application Ser. No. 12/702,723 and presently U.S. patent application Ser. No. 12/702,647, both of which were filed on Feb. 9, 2010 and both of which claim priority to now abandoned U.S. patent application Ser. No. 10/931,271 that was filed on Sep. 1, 2004 and bears the title of METHOD AND SYSTEM FOR INVASIVE SKIN TREATMENT.

FIELD OF THE INVENTION

The invention relates to methods and systems for skin treatment.

BACKGROUND OF THE INVENTION

Directed damage of the skin is used to stimulate regrowth of collagen and to improve skin appearance. A well known method of directed damage is ablating the epidermis using laser radiation having wavelengths strongly absorbed by water so as to heat the water to above boiling temperature. Typical lasers used for epidermis ablation are CO.sub.2 and Er:YAG lasers. Ablating the epidermis using RF (radiofrequency) current is described in U.S. Pat. No. 6,309,387. This treatment significantly reduces wrinkles and improves the skin appearance. The main disadvantages of skin resurfacing are the long healing period that can be over a month long and the high risk of dischromia. These disadvantages have reduced the popularity of ablative skin resurfacing in recent years.

Non-ablative skin resurfacing is based on heating of the dermis to a sub-necrotic temperature with simultaneous cooling of the skin surface. U.S. Pat. No. 5,810,801 describes penetrating the dermis with infrared laser radiation with dynamic cooling of the skin surface using a cryogen spray.

Wrinkles are created in skin due to the breakage of collagen fibers and to the penetration of fat into the dermal structure. Thus, destroying adipose cells and structure, can improve the surface structure. However, most wrinkle treatment methods target the collagen and do not have a significant effect on deep wrinkles Radio frequency (RF) energy has been used for the treatment of the epidermal and dermal layers of the skin. For example, U.S. Pat. No. 6,749,626 describes use of RF for collagen formation in dermis. This patent describes a method for collagen scar formation. U.S. Pat. Nos. 6,470,216, 6,438,424, 6,430,446, and 6,461,378 disclose methods and apparatuses for affecting the collagen matrix using RF with special electrode structures together with cooling and smoothing of the skin surface. U.S. Pat. Nos. 6,453,202, 6,405,090, 6,381,497, 6,311,090, 5,871,524, and 6,452,912 describe methods and apparatuses for delivering RF energy to the skin using a membrane structure. U.S. Pat. Nos. 6,453,202 and 6,425,912 describe methods and apparatuses for delivering RF energy and creating a reverse temperature gradient on the skin surface. Although a non-ablative treatment is much safer and does not scar the skin tissue, the results of non-ablative treatments are less satisfactory.

A method described in U.S. patent application No. 20030216719 attempts to maintain the efficiency of ablative treatment with a shorter healing time and a lower risk of adverse effects. The device described in that patent coagulates discrete regions of the skin where the regions have a diameter of tens of micrometers and the distance between the regions is larger than the regions themselves. This treatment provides skin healing within a few days but the results are very superficial and less spectacular than with CO.sub.2 laser treatment, even after multiple treatments.

U.S. Pat. No. 6,277,116 describes a method of applying electromagnetic energy to the skin through an array of electrodes and delivery electrolyte using a microporous pad.

A device for ablation of the skin stratum corneum using RF electrodes is described in U.S. Pat. Nos. 6,711,435, 6,708,060, 6,611,706, and 6,597,946. However, the parameters of this device are optimized for the ablation of the stratum corneum so as to enhance drug penetration into the skin, and not for thermal collagen remodeling.

SUMMARY OF THE INVENTION

The present invention provides a system and method for simultaneously heating skin at a plurality of discrete regions of the skin. The invention may be used for collagen remodeling. In accordance with the invention RF energy is applied to the skin at a plurality of discrete locations on the skin. The RF energy is applied using an electrode having a plurality of spaced apart protruding conducting pins. When the electrode is applied to the skin surface, each protruding conducting pin contacts the skin surface at a different location, so that the plurality of pins contacts the skin at a plurality of discrete locations. An RF voltage is then applied to the electrode so as to generate an electric current in the skin that heats the skin to a coagulation temperature simultaneously at a plurality of discrete regions of the skin. Coagulation temperatures are typically in the range of about 60.degree. C. to about 70.degree. C.

The protruding pins may have blunt tips which do not penetrate into the skin when the electrode is applied to the skin. In this case, the discrete regions of treated skin are located at the skin surface in the epidermis. Alternatively, the pins may have sharp tips that allow the protruding pin to penetrate the skin into the dermis. In this way, the discrete regions of treated skin are located in the dermis.

In another embodiment, the protruding elements are provided with sharp tips that allow the elements to penetrate into the skin. After application of the RF current in the skin, the protruding elements are pressed into the skin and an electrical current is then generated that coagulates tissue in the vicinity of the tip of each protruding element. The mechanical properties of the skin are changed after coagulation and the protruding elements may penetrate inside the skin without excessive pressure. A pre-pulse of RF energy can be applied to the skin in order to soften the skin tissue so as to facilitate penetration of the protruding elements into the skin.

The surface of the skin may be pre-cooled and/or cooled during the treatment to avoid damage to the skin in the area between protruding elements Skin cooling may be provided by contact cooling or by applying a pre-cooled liquid or cryogen spray.

The invention may be used in wrinkle treatment, collagen remodeling, skin tightening, loose skin treatment, sub-cutaneous fat treatment or skin resurfacing.

Thus in its first aspect, the invention provides a system for simultaneously heating a plurality of discrete skin volumes to a coagulation temperature, comprising:

    • (a) an applicator comprising an electrode having a plurality of spaced apart protruding conducting elements configured to contact the skin surface at a plurality of discrete locations; and
    • (b) a controller configured to apply a voltage to the electrode so as to simultaneously heat a plurality of skin volumes to a coagulation temperature when the applicator is applied to the skin surface.

In its second aspect, the invention provides a method for simultaneously heating a plurality of discrete skin volumes to a coagulation temperature, comprising:

    • (a) applying an applicator to the skin surface, the applicator comprising an electrode having a plurality of spaced apart protruding conducting elements configured to contact the skin surface at a plurality of discrete locations; and
    • (b) applying a voltage to the electrode so as to simultaneously heat a plurality of skin volumes to a coagulation temperature.

In the case when protruding part of the electrode penetrates within the skin the size of protruding elements should be small enough to avoid significant damage of the skin surface. Preferable size of protruding elements is from 10 to 200 microns and coagulation depth can be varied from 100 microns up to 2 mm for invasive electrodes.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be carried out in practice, preferred embodiments will now be described, by way of non-limiting examples only, with reference to the accompanying drawings, in which:

FIG. 1 shows a system for treating skin simultaneously at a plurality of discrete regions of skin, in accordance with the invention;

FIG. 2 shows an applicator for use in the system of FIG. 1;

FIG. 3 shows a second applicator for use in the system of FIG. 1; and

FIG. 4 shows a third applicator for use in the system of FIG. 1.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 shows a system for applying RF energy to a plurality of discrete regions of skin in accordance with the invention. The system includes an applicator 13, to be described in detail below, configured to apply RF energy simultaneously to a plurality of discrete regions of skin of an individual 22. The applicator 13 is connected to a control unit 11 via a cable 12. The control unit 11 includes a power source 18. The power source 18 is connected to an RF generator 15 that is connected to electrodes in the applicator 13 via wires in the cable 12. The control unit 11 has an input device such as a keypad 10 that allows an operator to input selected values of parameters of the treatment, such as the frequency, pulse duration and intensity of the RF energy. The control unit 11 optionally contains a processor 9 for monitoring and controlling various functions of the device.

FIG. 2 shows an applicator 13 a that may be used for the applicator 13 in accordance with one embodiment of the invention. The applicator 13 a comprises an electrode 1 from which a plurality of protruding conducting elements 5 extend. Each protruding element 5 (referred to herein as a “pin”) terminates in a tip 7 having a high curvature. The electrical current from the tips is much higher than from flat parts 6 of the electrode Skin volumes 4 around the tips 7 are therefore heated to a much higher temperature than the surrounding dermis 3 and epidermis 2, so that the skin volumes 4 may be heated to a coagulation temperature, while the skin temperature in the outside the volumes 4 are not heated to a coagulation temperature. The electrical energy is adjusted to selectively damage skin adjacent to tips so that the treatment of the skin occurs simultaneously at a plurality of discrete volumes 4. The pulse duration is preferably short enough to prevent significant heat diffusion far from the tips. In order to limit significant heat transfer from the tips, the pulse duration should preferably not exceed 200 ms. The selectivity of the treatment can be improved by electrode cooling of the skin surface. Cooling also causes a more uniform heat distribution at the tips. This can be achieved by circulating a cooling fluid through tubes 8 in the flat regions 6 between the pins 5. The electrode 1 is contained in a housing 10 connected to the cable 12. The cable 12 electrically connects the electrode 1 with a terminal of the power source 18. A second terminal of the power supply 18 may be connected to a ground electrode 20 via a cable 23 (See FIG. 1).

FIG. 3 shows an applicator 13 b that may be used for the applicator 13 in accordance with another embodiment of the invention. The applicator 13 b comprises an electrode 100 consisting of a plurality of conducting pins 101 extending from a conducting plate 102. The pins 101 are separated by electrical insulating material 105. The applicator 13 b is used similarly as the applicator 13 a to deliver electrical current to discrete volumes of skin 4.

The pins 5 in the applicator 13 a and the pins 101 in the applicator 13 b are provided with blunt tips 7 and 107, respectively. This prevents the pins 5 and 101 from penetrating into the skin when the electrode 13 a or 13 b is applied t the skin surface. Thus, the applicators 13 a and 13 b provide simultaneous non-invasive coagulation of skin regions 4.

FIG. 4 shows an applicator 13 c that may be used for the applicator 13 in accordance with another embodiment of the invention. The applicator 13 c is configured to be used for invasive collagen remodeling. The applicator 13 c includes an electrode 201 having a plurality of protruding conducting pins 205. The pins 205 have sharp tips 206 that are configured to penetrate through the epidermis 202 into the dermis 203 when pressed on the skin as shown in FIG. 4. The applicator 13 c is used similarly to the applicators 13 a and 13 b so that the treatment of the skin occurs simultaneously in a plurality of discrete skin volumes 204. However, unlike the discrete volumes 4, which are located in the epidermis (see FIGS. 2 and 3), the volumes 204 are located below the surface in the dermis 203 (FIG. 4). This reduces skin redness that sometimes occurs when the treated regions are in the epidermis. A maximal current density is created at the tips of the pins 205. The sides of the protruding elements may be coated with insulating material to avoid skin heating around the pins 205 (not shown).

The present invention can be combined with other methods of skin treatment including laser treatment. For example non-ablative collagen remodeling by laser radiation may be combined with the invasive RF heating of the skin dermis in accordance with the invention.

The preferable parameters for non-invasive skin coagulation in accordance with the invention are as follows: [0032] Electrode size above 0.3 cm; [0033] Protruding element at contact with the skin up to 0.5 mm [0034] Protruding element height about 1 mm. [0035] Distance between protruding elements at least twice the element diameter; [0036] Current density: over 1 A/cm.sup.2; [0037] RF current pulse duration: not longer than 0.5 sec; [0038] The optimal parameters for invasive skin coagulation: [0039] Electrode size above 0.3 cm; [0040] Pin diameter at contact with the skin not larger than 0.3 mm [0041] Pin protruding height above 1 mm. [0042] Distance between pins at least 1 mm; [0043] Current density above 0.1 A/cm.sup.2; [0044] RF current pulse duration not longer than 0.5 sec.

Claims (8)

What is claimed is:
1. An applicator for treating a plurality of discrete skin volumes, the applicator comprising:
a plurality of conducting elements configured to contact a skin surface at a plurality of discrete locations, each of the plurality of conducting elements including a distal high curvature blunt tip that prevents the tip from penetrating the skin and provides non-invasive treatment; and
an electrical insulating material disposed between the plurality of conducting elements to electrically separate the plurality of conducting elements from one another, wherein the plurality of conducting elements are configured for connection to an RF voltage source that is configured to apply an RF voltage to the plurality of conducting elements, and
wherein the plurality of conducting elements are configured such that a current density supplied from the RF voltage source at the distal tips is at least 1 Ampere/cm2 and when in contact with the skin surface and energized by the RF voltage source, cause selective simultaneous heating of the plurality of discrete skin volumes located in a dermal layer beneath the plurality of discrete locations.
2. The applicator of claim 1, further comprising a cooling element configured to cool the skin surface when the plurality of conducting elements are in contact with the skin surface.
3. The applicator of claim 2, wherein the cooling element is configured to circulate a cooling fluid between the plurality of conducting elements for cooling the skin surface.
4. The applicator of claim 2, wherein the cooling element is configured to apply a pre-cooled fluid to the skin surface when the plurality of conducting elements are in contact with the skin surface.
5. The applicator of claim 1, wherein the plurality of conducting elements are configured to apply the RF voltage in a pulse duration shorter than 0.5 sec.
6. An apparatus for simultaneously heating a plurality of discrete skin volumes to a coagulation temperature, the apparatus comprising:
an applicator configured to deliver energy to a skin surface, the applicator being configured to support a plurality of spaced apart protruding conducting elements configured to contact the skin surface at a plurality of discrete locations, each of the conducting elements terminated by a high curvature blunt tip that prevents the tip from penetrating the skin and provides non-invasive treatment; and
an RF energy source electrically connected to the applicator and configured to generate a current density at the distal tips of at least 1 Ampere/cm2 and enable an electrical current to pass to the skin via the conducting elements to simultaneously heat a plurality of discrete skin volumes to a coagulation temperature.
7. The apparatus of claim 6, wherein the applicator is configured to support the conducting elements such that the conducting elements are spaced apart by a distance of at least 1 mm, so that the conducting elements when applied to the skin surface contact the skin surface at spaced apart discrete locations.
8. The apparatus of claim 6, wherein the RF energy source is configured to cause selective heating of a plurality of the discrete skin volumes located in a dermal layer beneath the plurality of discrete locations.
US13/925,832 2004-09-01 2013-06-25 Method and system for invasive skin treatment Active US8771268B2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US10/931,271 US20060047281A1 (en) 2004-09-01 2004-09-01 Method and system for invasive skin treatment
US12/702,647 US8900231B2 (en) 2004-09-01 2010-02-09 Method and system for invasive skin treatment
US12/702,723 US20100185194A1 (en) 2004-09-01 2010-02-09 Method and system for invasive skin treatment
US12/876,765 US8579896B2 (en) 2004-09-01 2010-09-07 Method and system for invasive skin treatment
US13/925,832 US8771268B2 (en) 2004-09-01 2013-06-25 Method and system for invasive skin treatment

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/925,832 US8771268B2 (en) 2004-09-01 2013-06-25 Method and system for invasive skin treatment
US14/174,011 US20140221990A1 (en) 2004-09-01 2014-02-06 Application of energy with cooling elements for skin treatment

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US12/876,765 Continuation US8579896B2 (en) 2004-09-01 2010-09-07 Method and system for invasive skin treatment

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US14/174,011 Continuation US20140221990A1 (en) 2004-09-01 2014-02-06 Application of energy with cooling elements for skin treatment

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US20130289554A1 US20130289554A1 (en) 2013-10-31
US8771268B2 true US8771268B2 (en) 2014-07-08

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US10/931,271 Abandoned US20060047281A1 (en) 2004-09-01 2004-09-01 Method and system for invasive skin treatment
US12/702,647 Active 2026-06-04 US8900231B2 (en) 2004-09-01 2010-02-09 Method and system for invasive skin treatment
US12/702,723 Abandoned US20100185194A1 (en) 2004-09-01 2010-02-09 Method and system for invasive skin treatment
US12/876,765 Active 2025-06-16 US8579896B2 (en) 2004-09-01 2010-09-07 Method and system for invasive skin treatment
US13/028,216 Active 2025-06-27 US8906015B2 (en) 2004-09-01 2011-02-15 Method and system for invasive skin treatment
US13/925,832 Active US8771268B2 (en) 2004-09-01 2013-06-25 Method and system for invasive skin treatment
US14/174,011 Abandoned US20140221990A1 (en) 2004-09-01 2014-02-06 Application of energy with cooling elements for skin treatment

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US10/931,271 Abandoned US20060047281A1 (en) 2004-09-01 2004-09-01 Method and system for invasive skin treatment
US12/702,647 Active 2026-06-04 US8900231B2 (en) 2004-09-01 2010-02-09 Method and system for invasive skin treatment
US12/702,723 Abandoned US20100185194A1 (en) 2004-09-01 2010-02-09 Method and system for invasive skin treatment
US12/876,765 Active 2025-06-16 US8579896B2 (en) 2004-09-01 2010-09-07 Method and system for invasive skin treatment
US13/028,216 Active 2025-06-27 US8906015B2 (en) 2004-09-01 2011-02-15 Method and system for invasive skin treatment

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